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Oral contraceptive labeling

Executive Summary

FDA's Fertility and Maternal Health Drugs Advisory Committee recommended unanimously at its Feb. 8 meeting that the "taking the pill" instruction section of oral contraceptive patient package inserts should be "standardized and simplified." The committee called for instructions written at a fifth or sixth grade reading level, with large print and simple illustrations of the pill dispenser. They also unanimously endorsed a set of patient instructions designed by the nonprofit population research group of Family Health International as a suitable model for future labeling.
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PS018770

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